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Laser Acupuncture on Dry Eye and Sjögren's Syndrome-related Dry Eye Symptoms (LADESJS)

RecruitingPhase 2Ages 20 Years - 75 YearsAllTaipei Veterans General Hospital, Taiwan
NCT06780293 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of adding laser acupuncture at Fengchi (GB20), Zanzhu (BL2), Hegu (LI4), and Quchi (LI11) acupoints to standard care for the treatment of dry eye symptoms in both Sjögren's Syndrome-related dry eye (SJS-DES) and non-Sjögren's Syndrome-related dry eye (Non-SJS-DES) populations. A total of 140 dry eye patients will be recruited and divided into two groups: 70 participants with SJS-DES and 70 with Non-SJS-DES. Participants will be randomly assigned into three groups: Sham+LA group (60 participants receiving 4 weeks of placebo laser acupuncture followed by 4 weeks of active laser acupuncture), LA+LA group (60 participants receiving 4 weeks of active laser acupuncture followed by another 4 weeks of active laser acupuncture), and a Waiting List group (20 participants receiving no laser acupuncture tr

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📋 Eligibility rules (as published)
• Dry eye syndrome Inclusion Criteria: 1. aged between 20 and 75 years 2. Schirmer's test less than 10 mm/5 min Exclusion Criteria: 1. Pregnancy 2. With eye inflammation or infectious eye disease 3. Accepted operation of eye * Sjögren's syndrome Inclusion Criteria: 1. primary or secondary SS 2. aged between 20 and 75 years 3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG) 4. had no abnormal findings of immune, liver, kidney, or blood function evaluations. Exclusion Criteria: 1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition 2. pregnancy or breastfeeding 3. steroid pulse therapy within three months prior to the commencement of our study.
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What it tests

  • Laser acupuncture (LA)
  • Numerical Rating Scale (NRS)
  • Schirmer's test
  • Ocular Surface Disease Index (OSDI)
  • EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)
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Where

1 site
Ching-Mao Chang
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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